Therapy of Early Chronic Phase Chronic Myelogenous Leukemia (CML) With SCH54031 (PEG Interferon Alpha 2B/PEG Intron) and Low-Dose Cytosine Arabinoside (Ara-C)
If you agree to take part in this study, during treatment, you will have blood tests every 1
to 4 weeks. After 10 years, blood tests are recommended 2 times per year. Bone marrow
samples will be taken every 3 months during the first year and then every 3 to 6 months. If
you are on this study for 10 years or longer, the bone marrow collections will only be
performed if the doctor thinks it is needed. To collect a bone marrow biopsy, an area of the
hip is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn
through a large needle.
During treatment, you will receive PEG-Intron once a week. You will also receive Ara-C
injections under the skin. You will be taught to inject yourself, or a family member or
friend can be taught how to give injections. Treatment will be given to you in the
outpatient clinic at MD Anderson or in a clinic close to you.
You will receive treatment as long as it is helping to control the disease. Treatment will
go on for about 5 to 20 years.
This is an investigational study. The FDA has approved PEG-Intron only for research
studies. About 100 patients will take part in this study. All will be enrolled at MD
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete Cytogenetic Response Rate after One Year on Therapy
Jorge E Cortes, MD
The University of Texas N.D. Anderson Cancer Center
United States: Food and Drug Administration
|The University of Texas M.D. Anderson Cancer Center||Houston, Texas|